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Corporate Governance

News

Following an extensive audit by the United Kingdom Accreditation Service (UKAS), LRQA has been granted accreditation to ISO 13485:2016, the international quality management system (QMS) standard for organisations involved in medical device manufacturing.

The International Aerospace Quality Group (IAQG) has now published AS9110:2016 and AS9120:2016. This completes the revision of the core Aerospace Standards and represents the revised quality standard for aviation, defence and space organisations.

Following a week of meetings in June 2016, during which ISO 45001 - the new occupational health and safety standard being developed by the International Organization for Standardization (ISO) - moved to a second draft international standard (DIS2) stage, ISO/PC 283/WG1, the Working Group responsible for developing the new standard, met three weeks ago in Lithuania.

The medical regulatory landscape is said to be undergoing its most significant overhaul in years. The new European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) have been four years in the making, and are likely to be published in Q1 2017.

Events

The new Medical Device Regulation (MDR) will replace the existing Medical Device Directive (MDD) 93/42/EEC. The Regulation is currently in the final stage of development and are expected to be published towards the end of Q1 2017.

Understanding the importance of context, risk, and process
Following on from the Leadership Series, let’s now look at the importance of Context of the Organisation, Risk-Based Thinking and Process Management.

The new In Vitro Diagnostic Device Regulation (IVDR) will replace the existing In Vitro Diagnostic Device (IVD) Directive 98/79/EC. The Regulation is currently in the final stage of development and are expected to be published towards the end of Q1 2017.

Case studies

Trident Medical Services (TMS) are occupational health experts specialising in the high-risk and regulated industries. When their existing certification was due to expire Trident Medical Services took the decision to become an early adopter.

Infotech Ltd has become one of the first companies in their industry sector to successfully achieve certification to ISO 9001:2015 with our registration body Lloyd’s Register (LRQA) since its release in September 2015.

Nuvia has become one of the first companies in the nuclear sector to successfully achieve certification to ISO 9001:2015 with our registration body Lloyd’s Register (LRQA) since its release in September 2015.